BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇺🇸 United States

    TRIMFLO PARENCHYMAL BLOOD FLOW MONITORING PROBE KIT

    K Number: K961368 · Decision Oct 11, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    47
    Applicant Total
    6
    Review Days
    185

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    Basic Information

    Device Name
    TRIMFLO PARENCHYMAL BLOOD FLOW MONITORING PROBE KIT
    K Number
    K961368
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2120
    Medical Specialty
    Cardiovascular
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Vasamedics, LLC
    Date Received
    April 9, 1996
    Decision Date
    October 11, 1996
    Product Code
    DPT
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DPT Probe, Blood-Flow, Extravascular

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    Other Clearances by Vasamedics, LLC

    K Number Device Name
    K962700 VENTRICULAR CATHETER BLOOD FLOW MONITORING PROBE KIT AND VENTRAFLO BLOOD FLOW MONITORING PROBE KIT
    K951832 LASERFLO BLOOD PERFUSION SINGLE USE PROBES MODELS SUP-440, SUPR-434 SUP-433
    K951486 MODEL PV2000 VASCULAR MICROLABORATORY
    K912446 MODIF. LASERFLO BLOOD PERFUSION MONITOR MODEL BPM2
    K911763 LASERFLO(R) BLOOD PERFUSION MONITOR (MODEL BPM2)